Building a Manual Visual Inspection process from scratch

Implementing 100% Manual Visual Inspection (MVI) 

Ardena, a leading pharmaceutical CDMO, expanded its capabilities in Ghent with a new sterile fill & finish facility a couple of years ago. This step allowed the company to move beyond non-sterile products and start manufacturing injectable Investigational Medicinal Products (IMPs) for customers worldwide. 

With sterile manufacturing comes a critical requirement: every vial must undergo 100% Manual Visual Inspection (MVI). For Ardena, this meant setting up an entirely new MVI department, without any existing processes, experience, or tools in place. 

“Visual inspection is so specific that you can’t just rely on guidelines. You really need hands-on training and expertise.” 
— Wannes Deckers, Associate Director Quality & Qualified Person at Ardena. 

Building a GMP-compliant MVI process 

When Ardena launched its sterile facility, the infrastructure and inspection booths were ready, but the foundation for MVI still needed to be built. The challenges were clear: 

• No existing processes: Procedures had to be developed step by step and made compliant with GMP standards. 

• Operator qualification: A new team without prior Manual Visual Inspection experience needed to be trained and qualified. 

• Customized test kits: Test kits were required to represent real-life product defects and support both training and qualification.  

In short: Ardena needed to build an MVI process from scratch. 

eyetec guides Ardena’s MVI training and processes 

To meet these challenges, Ardena partnered with eyetec, specialists in visual inspection processes and training. Compliance Director & QP at eyetec, Bram Keymolen, and his team supported Ardena in three critical areas: 

1. Process development and compliance feedback 

Ardena and eyetec worked closely to draft, review, and fine-tune the MVI procedures. In regular follow-up meetings, eyetec provided detailed feedback, helped identify process gaps, and ensured that every step aligned with regulatory requirements. 

1. Test kits for training and qualification 

Together, Ardena and eyetec designed customized test kits containing relevant defects to train and qualify operators. These kits are still used to ensure inspectors maintain their skills and to represent actual defect scenarios encountered across the different product types handled at Ardena 

1. On-site training and first practical batch inspection 

An eyetec visual inspection expert provided on-site training for Ardena operators and was also present during their first real water batch inspection. This combination of hands-on instruction and practical guidance helped the team gain confidence, develop accuracy, and apply the MVI process effectively from day one. 

“With eyetec’s support, we built a system that works. Their feedback and practical guidance were invaluable.” 
— Wannes Deckers. 

Results 

Thanks to the collaboration with eyetec, Ardena now has a fully operational MVI process: 

• Six inspection workstations are running smoothly. 

• Operators are trained, qualified, and able to perform weekly inspections. 

• Procedures are documented, compliant, and aligned with GMP requirements. 

• The team has developed hands-on skills and confidence in conducting visual inspections according to GMP standards. 

The partnership delivered not just compliance, but also peace of mind. Ardena’s QP can now rely on a process that is robust, validated, and ready for regulatory scrutiny. 

“eyetec combines deep expertise with a personal approach. Bram was directly involved, and every call was tailored to our needs. From process advice to test kits and training, they offered the complete package. We would definitely recommend them.” 
— Wannes Deckers.